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Effect of Continuous vs Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes

2019年7月1日 更新者:Kristyn Kirton、Springfield College

The Effect of Continuous Versus Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes - A Crossover Randomized Control Trial

The purpose of this study will be to evaluate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels, in a sample of type 2 diabetes patients, aged 30-65 years, living in Barbados

Research Hypotheses:

The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower post prandial blood sugar levels when compared to the single bout of moderate intensity aerobic exercise.

The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower fasting blood sugar levels on the morning following the exercise intervention when compared to the single bout of moderate intensity aerobic exercise

研究概览

详细说明

With the background that there is increasing evidence that breaking up sedentary time with physical activity may be potentially associated with improved blood glucose levels (Francois et al., (2014) & van Dijk et al., (2013), this study aims to investigate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels in a sample of type 2 diabetes patients.

Different from previous studies, this research seeks to evaluate these effects in a Black Caribbean population, in a type 2 diabetes population on medication including insulin and also seeks to evaluate if either exercise regimen is indeed palatable to the target population by evaluating treatment acceptability.

The proposed study will be a crossover randomized controlled study. There will be two intervention groups - a single 30-minute bout of moderate intensity aerobic exercise before breakfast and three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner. The primary outcome measure will be 2-hr post prandial blood sugar levels and fasting blood sugar levels on the day following the intervention. Neither subject nor investigator will be blinded to the intervention.

Subjects will include patients with a documented diagnosis of type 2 diabetes, that is a documented HbA1C ≥ 6.5%. Baseline data will include body mass and body composition and will be measured using the bioelectrical impedance technique (Tanita scale). Waist circumference will be assessed using a Gulick tape measure. Baseline sedentary behaviour and physical activity level will be assessed using the validated International Physical Activity Questionnaire.

All recruited subjects will be asked to complete two exercise interventions separated by a one-week washout period: 1) a single 30-minute bout of moderate intensity aerobic exercise before breakfast and 2) three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner. Each subject will be randomized to one of two treatment sequences: single bout followed by multiple bouts (S-M) or multiple bouts followed by single bout (M-S). The randomization will be done using online statistical computing web programming (www.randomization.com) to generate a randomization schedule with balanced permutations.

Timing between exercise completion and commencement of meal intake will be approximately 15 minutes. A heart rate reserve range of 40-59% will be used to define moderate intensity. Heart rate will be measured using a validated Polar heart rate monitor. Rate of perceived exertion will be a secondary measure of exercise intensity.

Two-hour (2hr) post prandial blood sugar levels and fasting blood sugar levels on the day following the exercise intervention will be measured using a validated capillary blood glucose meter. Blood pressure will also be measured at the same times that blood glucose values are taken using a validated automated blood pressure machine.

Standardized meals of fixed nutrient content and individualized to the subject's calculated estimated daily caloric requirements will be provided to subjects on the day of the exercise interventions. Treatment acceptability will be assessed following each exercise intervention using an expert-designed questionnaire that will be piloted in this study.

研究类型

介入性

注册 (预期的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 30-65 years
  • Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)

Exclusion Criteria:

  • Subjects currently managed on prandial insulin
  • Subjects who have recently started insulin (within the previous month)
  • Subjects with a history of frequent hypoglycemic episodes within the previous 2 weeks,
  • Pregnancy
  • Subjects with a history of cerebrovascular accident, myocardial infarction, chronic kidney disease, autonomic and peripheral neuropathy
  • Subjects with contraindications to exercise according to ACSM 2018 guidelines

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Single Bout ('S') - 30 minutes of moderate intensity cycling
Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast
Each subject will perform a single bout of 30-minutes of moderate-intensity cycling before breakfast
实验性的:Multiple Bout ('M')
Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner
Each subject will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
2 hour post prandial blood glucose level after breakfast
大体时间:single point measurement taken 2 hours after breakfast consumption
blood glucose level 2 hours after breakfast consumption
single point measurement taken 2 hours after breakfast consumption
2 hour post prandial blood glucose level after lunch
大体时间:single point measurement taken 2 hours after lunch consumption
blood glucose level 2 hours after lunch consumption
single point measurement taken 2 hours after lunch consumption
2 hour post prandial blood glucose level after dinner
大体时间:single point measurement taken 2 hours after dinner consumption
blood glucose level 2 hours after dinner consumption
single point measurement taken 2 hours after dinner consumption
Fasting blood sugar level
大体时间:single point measurement taken after 8 hours of fasting
blood sugar level after 8 hours of fasting performed on day following exercise intervention
single point measurement taken after 8 hours of fasting

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Samuel Headley, PhD、Springfield College

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年7月1日

初级完成 (预期的)

2020年2月1日

研究完成 (预期的)

2020年4月1日

研究注册日期

首次提交

2019年6月29日

首先提交符合 QC 标准的

2019年7月1日

首次发布 (实际的)

2019年7月5日

研究记录更新

最后更新发布 (实际的)

2019年7月5日

上次提交的符合 QC 标准的更新

2019年7月1日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • KCK00000001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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